BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GENESIS (MS-P02-GEN)

    K Number: K240843 · Decision Oct 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    194

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    Basic Information

    Device Name
    GENESIS (MS-P02-GEN)
    K Number
    K240843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5150
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Climbing Steps, Inc.
    Date Received
    March 27, 2024
    Decision Date
    October 7, 2024
    Product Code
    ILK
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILK Transport, Patient, Powered

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